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Introduction: Fospropofol disodium is a novel prodrug that has improved pharmacokinetic and pharmacodynamic properties compared with propofol. This trial aims to compare the efficacy and safety of fospropofol versus propofol sedation for same-day bidirectional endoscopy in elderly patients.
Methods and analysis: This is a prospective, single-center, double-blind, randomized, propofol-controlled, non-inferiority trial. A total of 256 adult patients scheduled for same-day bidirectional endoscopy under sedation will be randomly allocated, in a 1:1 ratio, to a fospropofol group or a propofol group (n=128 in each group). All patients will receive analgesic pretreatment with sufentanil 5 μg. Two minutes later, an initial bolus dose of fospropofol 6.5 mg/kg or 1.5 mg/kg propofol and supplemental doses of fospropofol 1.6 mg/kg or 0.5 mg/kg propofol will be titrated as needed to the target sedation levels during the procedures. The primary outcome is the success rate of same-day bidirectional endoscopy. Secondary outcomes include the time to successful induction of sedation, duration, time to being fully alert, time to patient discharge, endoscopist satisfaction, patient satisfaction, and the top-up frequency and dosage of sedative medications. The safety endpoints consist of adverse events (AEs) concerning cough reflex, gag reflexes, body movement, muscular tremor, pain on injection. Sedation-related AEs, including episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia, will be also recorded. Data will be analyzed on the intention-to-treat basis.
Discussion: The investigators hypothesize that the efficacy and safety of fospropofol sedation for elderly patients undergoing same-visit bidirectional endoscopy will not be inferior to that of propofol. The findings will provide daily practice of sedation regimens for same-day bidirectional endoscopy in elderly patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fospropofol | Experimental |
| |
| propofol | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fospropofol sedation | Drug | Fospropofol sedation for same-day bidirectional endoscopy in elderly patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of same-day bidirectional endoscopy | The success rate of the gastrointestinal endoscopy was assessed according to the following criteria : 1) completion of the gastrointestinal endoscopy; 2) no need for rescue sedative/anesthetic, which means the top-up doses of the experimental drugs were administered no more than five times within any 15-min window from the initial administration to the end of the procedure. | Immediate time after sedation emergence |
| Measure | Description | Time Frame |
|---|---|---|
| The time to successful induction of sedation | the time counted from the start of drug administration to the achievement of a sedation score (MOAA/S ) ≤ 1 | Immediate time after sedation emergence |
| Time to being fully alert |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | propofol |
|
the time from gastrointestinal endoscopy extraction or/and the time from the last drug administration to a MOAA/S score of 5 on three consecutive measurements;
| Immediate time after sedation emergence |
| Time to patient discharge | Time to patient discharge | Immediate time of hospital discharge |
| Endoscopist's satisfaction questionnaire | Endoscopist's satisfaction | Immediate time after sedation procedure completion |
| Patient's satisfaction questionnaire | Patient's satisfaction | Immediate time of hospital discharge |
| The top-up frequency and dosage of sedative medications | The top-up frequency and dosage of sedative medications | Immediate time after sedation emergence |
| Incidence of adverse events (AEs) at timepoint 1 | Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia. | baseline (Prior to sedation) |
| Incidence of adverse events (AEs) at timepoint 2 | Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia. | Intraoperative (during sedation) |
| Incidence of adverse events (AEs) at timepoint 3 | Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia. | Intraoperative (the timepoint of sedation emergence) |
| Incidence of adverse events (AEs) at timepoint 4 | Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia. | 15 min in post-anesthesia care unit |
| Incidence of adverse events (AEs) at timepoint 5 | Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia. | 30 min in post-anesthesia care unit |
| Incidence of adverse events (AEs) at timepoint 6 | Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia. | Immediate time of hospital discharge |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |